510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay Phencyclidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jun 25, 2013 as substantially equivalent to K101059 (Omega Laboratories, Inc., 2010) after a 61-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jun 25, 2013
- Review
- 61 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011275 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK011275 Psychemedics Ria Phencyclidine AssayPsychemedics Corp. · 2002
- 1 generation backK101059 Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc. · 2010
- This deviceK131181 Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011275 | Psychemedics Ria Phencyclidine Assay | Psychemedics Corp. | 2002 | — |
| −1 | K101059 | Omega Laboratories Hair Drug Screening Assay for Phencyclidine | Omega Laboratories, Inc. | 2010 | — |
| 0 (this device) | K131181 | Omega Laboratories Hair Drug Screening Assay Phencyclidine | Omega Laboratories, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101059 | Omega Laboratories Hair Drug Screening Assay for PhencyclidineSummary page 2…in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established. 2.0 PREDICATE DEVICES Omega Laboratories Hair Drug Screening Assay Phencyclidine (k101059) 3.0 INTENDED USE AND INDICATIONS FOR USE The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an in vitro diagnos… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. To confirm a…
Read the full statement (147 words)
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131181: Omega Laboratories Hair Drug Screening Assay Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131181
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026